Desafios da química analítica frente às necessidades da indústria farmacêutica

The development of liquid chromatography-mass spectrometric (LC-MS) techniques in the last few decades has made possible the analysis of trace amounts of analytes from complex matrices. With LC, the analytes of interest can be separated from each other as well as from the interfering matrix, after which they can be reliably identified thanks to the sensitivity and specificity of MS. LC-MS has become an irreplaceable tool for many applications, ranging from the analysis of proteins or pharmaceuticals in biological fluids to the analysis of toxic substances in environmental samples. In different segments of Brazilian Industry mass spectrometry has an important role, e.g. in the pharmaceutical industry in the development of generic formulations, contributing to the growth of Industry and social inclusion. However, the Brazilian chemists until this moment don't have an effective role in this new segment of the analytical chemistry in Brazil. The present paper shows the actual scenario for mass spectrometry in the pharmaceutical industry, emphasizing the need of a revision of graduation courses to attend the needs of this growing market.

Validação de método para determinação de resíduos de amoxicilina aplicado à validação de limpeza em indústria farmacêutica de penicilânicos

The aim of this work was the single-laboratory validation of a quantitative method for the determination of amoxicillin residues in support of cleaning control and validation. Linearity was demonstrated between 2.5 and 17.5 μg/mL, without matrix effects. Mean recoveries ranged from 84.00 to 103.74% and the relative standard deviation under repetitivity and within-reproducibility conditions were from 0.58 to 4.20% and from 0.79 to 4.39%, respectively. The theoretical limits of detection and quantification were 0.133 and 0.442 μg/mL, respectively. The studied method was suitable for cleaning control purpose within good manufacturing practices.

Análise térmica aplicada a fármacos e formulações farmacêuticas na indústria farmacêutica

Several matters of the pharmaceutical demonstrate the great importance of thermal analysis application, especially TG and DSC for the pharmaceutical industry future, namely: characterization of the drugs with the thermal events definition, in studies of drug purity, in the polymorphs identification, in compatibility studies of solid dosage pharmaceutical formulations, in drugs and pharmaceutical formulations thermal stability, and in determination of shelf life for isothermal degradation kinetics by extrapolation using the Arrhenius equation. Thus, the test results obtained from thermal analysis are directly related to the quality of a pharmaceutical product, whether the stability or bioavailability of the pharmaceutical product.

Desafios da indústria farmacêutica brasileira

The paper traces a panorama of the development of new drugs and hopes to contribute for Brazil to become a player in the discovery of new drugs. Brazil is the sixth world market retail consumer of medicines prone to expansion, has a pharmaceutical industry focused on the production of generics and a very large number of undergraduate courses in Pharmacy. The national industry has grown over the last decade after the Generics Act 9787/99. Despite these positive aspects, a number of bottlenecks prevent Brazilian pharmaceutical industry to invest in the development of new drugs. There are, however, a number of initiatives to reduce the dependence on imported generic drugs. It is a very good start for the development of new pharmaceutical drugs.

Médicos e indústria farmacêutica: percepções éticas de estudantes de medicina

INTRODUÇÃO: Após a Segunda Guerra Mundial, a indústria farmacêutica (IF) consolidou-se como importante e lucrativa atividade econômica. Considerando que os prescritores são médicos, a IF se vale de pesada campanha propagandística e do oferecimento de vantagens, desde os primórdios da formação médica. OBJETIVOS: Identificar percepções éticas em estudantes de Medicina no início do curso, além de comparar os distintos grupos que compõem a amostra. CASUÍSTICA E MÉTODOS: Estudo transversal, descritivo, baseado na aplicação e análise de questionário sobre a relação entre médicos e IF, respondidos por 94 segundanistas. Para análise estatística, utilizaram-se testes do tipo Wilcoxon e Exato de Fisher. A significância foi de p = 0,5. RESULTADOS: As respostas foram semelhantes aos conceitos do Código de Ética Médica (CEM) de 1988. Na comparação entre grupos relativamente ao item que declarava a necessidade de maior tempo de abordagem de temas éticos, verificou-se divergência entre estudantes religiosos e aqueles sem religião declarada. DISCUSSÃO: A influência das ações da IF era conhecida entre os alunos, ainda que ignorassem certos mecanismos de atuação desta e se tornassem vulneráveis à propaganda em ambiente acadêmico. CONCLUSÃO: As percepções éticas dos estudantes pesquisados foram, em geral, homogêneas na amostra e estão em conformidade com o CEM. Reconheceram a necessidade de contínua discussão sobre o assunto